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Country's Decision or any other Communication
Record information and status
Record ID
111658
Status
Published
Date of creation
2017-02-22 11:32 UTC (german_bch@bvl.bund.de)
Date of last update
2020-11-23 12:19 UTC (german_bch@bvl.bund.de)
Date of publication
2020-11-24 12:22 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
6786-01-0085 (adv. 42010-0085); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified maize (Zea mays), offspring of T25, issued by the German Competent Authority
Date of the decision
1998-05-14
Is the decision taken prior to entry into force of the Protocol?
Yes
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Bayer CropScience
Bayer CropScience Deutschland GmbH
Bayer CropScience AG
Alfred-Nobel-Str. 50
40789 Monheim am Rhein
Monheim am Rhein
Germany, 40789
Phone:+49 21 73 - 38-0
Url:Bayer CropScience
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
-  Fertile plant material has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory. The spillage of seeds has to be avoided.
If flowers are transported outside of the field site the spreading of pollen has to be prevented.
-  All machines that have been used on the release site have to be thoroughly cleaned on the release site.
-  The germination capacity of all plant material that is not moved to a genetic engineering facility All remaining fertile plant material, including the non-genetically modified maize shelter cropsplanted to surround the field site and harvested corncobs of those has to be destroyed by chopping and subsequent digging under the soildisruption of their germination capacity.
-  IInspection of the release site has to be conducted in the year following the observation of genetically modified maize volunteers. The follow-up inspection needs to include the whole release site and a 5 m band around the site. During the vegetation period the release site must be inspected for transgenic volunteer maize at least once every four weeks. The inspection period has to be extended for another year if maize volunteers were observed, and the volunteer plants have to be destroyed.
Reasons
To comply with requirements of Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
ACS-ZMØØ3-2 - Liberty Link™ maize
Resistance to antibiotics - Ampicillin Resistance to herbicides - Glufosinate
Show detection method(s)
Risk assessment
6786-01-0085 (adv. 42010-0085) Summary of the risk assessment of a deliberate release (field trial) of genetically modified maize (Zea mays), offspring of T25, issued by the German Competent Authority
ACS-ZMØØ3-2 - Liberty Link™ maize
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: offspring of T25
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 14 May 1998 to 31 December 2003
-  locations: 1 experimental fieldslocated in 1 village in Germany, for details refer to the German LMO/GMO lcation register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 2700 m²/site/year
-  max. 27.000 LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/85

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.